Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioCryst Pharmaceuticals
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
Failure to have responded to one or more standard regimens for their disease.
Performance status of \<=2 by Eastern Cooperative Oncology Group (ECOG) criteria
All ages are eligible
Life expectancy of at least 3 months
Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \>3 times upper limits or normal \[ULN\])
Adequate kidney function (calculated creatinine clearance \>50 mL/min)
Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential
Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study
Signed informed consent/assent form (ICF) prior to start of any study specific procedures
You may not be if
Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
Patients with known Hepatitis B and/or Hepatitis C active infection
Patients with active CMV infection
Tumor-related central nervous system (CNS) leukemia requiring active treatment
Active serious infection not controlled by oral or IV antibiotics
Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
